Regulations/Legal

Editor's Note The Food and Drug Administration (FDA) on January 7 issued a statement from Commissioner Scott Gottlieb, MD, on the agency’s new actions under the Digital Health Pre-Certification (Pre-Cert) Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations. Because digital…

Editor's Note In the first 2 years of Medicare’s Comprehensive Care for Joint Replacement (CJR) program, there was a modest reduction in spending per procedure without an increase in complication rates, this study finds. Comparing costs associated with 280,161 joint replacement procedures in 803 hospitals required to participate in the…

Editor's Note The Joint Commission announced on December 19 that, effective July 1, 2020, it will begin publicly reporting hospitals with consistently high C-section rates on"Quality Check," using hospital data reported during CY 2018 and 2019. The Joint Commission began requiring accredited hospitals to collect and submit data on the…

Editor's Note The Food and Drug Administration (FDA) on December 20 announced that fluoroquinolone antibiotics can increase the occurrence of ruptures or tears in the aorta. The FDA recommends that healthcare professionals: Avoid prescribing fluoroquinolone antibiotics to patients who have or are at risk for having an aortic aneurysm, and…

In the past few months, the Joint Commission has implemented a new process for accreditation surveys and changed the wording and interpretation of some standards, particularly infection control. At the 2018 OR Manager Conference in Nashville, Tennessee, in September, John R. Rosing, MHA, FACHE, executive vice president and principal of…

Flipping rooms, or running two ORs back to back, is common in many perioperative services departments. Certain rules of thumb can help ensure efficiency and good outcomes, but sometimes those rules either don’t exist or are unclear. Does your facility have guidelines for overlapping surgery, and do your surgical teams…

Editor's Note The Society for Healthcare Epidemiology of America (SHEA) on December 11 published a new expert guidance on “Infection prevention in the operating room anesthesia work area.” Key recommendations of the guidance to improve infection prevention include: Increased hand hygiene performed, at a minimum, before aseptic tasks, after removing…

Editor's Note The Food and Drug Administration (FDA) on December 10 issued a statement on an updated safety communication about rates of duodenoscope contamination obtained from preliminary postmarket data. Interim results from sampling studies from device manufacturers−Olympus, Fujifilm, and Pentax− indicate higher-than-expected contamination rates after reprocessing. Up to 3% of…